Study Coordinator

3 semanas atrás


Lisboa, Portugal CUF - Hospitais e Clínicas Tempo inteiro

Somos uma empresa 100% portuguesa, líder na prestação de cuidados de saúde de excelência em Portugal, que conta com mais de 75 anos de experiência e uma rede de 23 Hospitais e Clínicas CUF distribuídas pelo país. Baseamo-nos em valores como: o Respeito, a Dignidade, o Bem-Estar das Pessoas, a Integridade, o Desenvolvimento Humano, a Competência e a Inovação.

Queremos atrair os melhores profissionais para colaborarem numa organização líder de mercado, que trabalha diariamente para atingir a excelência. Estamos a recrutar um **Coordenador de Estudos Clínicos**, para o Hospital CUF Descobertas.

**Local de Trabalho**:Hospital CUF Descobertas, Parque das Nações.

**Missão**:Acompanhar e dar suporte às equipas de investigação, na condução de estudos clínicos (ensaios clínicos e estudos observacionais) desenvolvidos pela indústria, e contribuir para o desenvolvimento da investigação interna.

**Quais as principais responsabilidades **do Coordenador de Estudos Clínicos?**
- Assegurar o acompanhamento dos Estudos Clínicos (ensaios clínicos e estudos observacionais) e projectos de investigação na CUF;
- Divulgar internamente os projetos e confirmar a possibilidade de participação de todos os serviços envolvidos nos estudos sob a sua coordenação;
- Divulgar os critérios de inclusão e exclusão dos ensaios para recrutamento interno e referenciação de clientes;
- Participar nas reuniões de qualificação do Centro/Unidade;
- Registar na Base de Dados/ficheiros do Centro a actividade realizada no prazo instituído;
- Assegurar a formação dos investigadores, enfermeiros, farmacêuticos, técnicos de acordo com o protocolo do ensaio;
- Recolher e atualizar toda a documentação necessária ao processo de submissão;
- Preparar informação relativa ao ensaio para submissão à DPO e Comissão de Ética e Jurídica;
- Preencher os CRFs (Case Report Forms) de acordo com o processo clínico do cliente e proceder ao respetivo envio em plataforma do ensaio clínico, incluindo resposta a discrepâncias;
- Identificar a informação em falta no processo, e assegurar a atualização da mesma em processo clínico pelo profissional responsável;
- Arquivar a documentação no dossier do Investigador e assegurar a sua manutenção com os documentos atualizados tendo em conta emendas e adendas;
- Organizar o procedimento de reembolso de despesas de cada participante incluído no Ensaio Clínico, acedendo aos seus dados;
- Garantir o envio de colheitas/amostras solicitadas pelo promotor de acordo com protocolo;
- Garantir a melhoria contínua dos processos, procedimentos e soluções.

**O que valorizamos?**
- Experiência profissional mínima de 1 ano em funções similares;
- Ensino superior em áreas relevantes (Ciências Farmacêuticas, Biologia, Biomédica e similiares);
- Estágio Mestrado Investigação Clínica;
- Conhecimento de Inglês;
- Conhecimento de (GCP) Good Clinical Practice.
- ** Experiência prévia como Study Cooordinator;**:

- ** Chefe de equipa;**

**O que pode esperar de nós?**
- Contrato de trabalho direto com a CUF;
- Formação inicial e contínua, através da CUF Academic Center;
- Valorização dos nossos recursos humanos através do crescimento e reconhecimento dentro da empresa (Gestão de Desempenho, Mobilidade Interna, entre outros);
- Entidade familiarmente responsável, reconhecendo a importância da conciliação entre a vida profissional, pessoal e familiar, com oferta de benefícios nesse sentido (apoios para nascimentos, cabaz escolar, 40h anuais para realização de voluntariado, bolsas para frequência do ensino superior, entre muitos outros).

**Quer juntar-se à equipa CUF?


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